Some important and common forms of blindness result from degeneration of the rods and cones of the eye and in these cases the sole output cells (i.e., ganglion cells) are relatively spared. The development of a fully functioning intraocular prosthesis integrated into a single unit has been a long time goal.
In the human eye, the ganglion cell layer of the retina becomes a monolayer at a distance of 2.5-2.75 mm from the foveola center. Since the cells are no longer stacked in this outer region, this is the preferred location for stimulation with an epiretinal electrode array. The feasibility of a visual prosthesis operating on such a principle has been demonstrated by Humayun et al. in an experiment in which the retinas of patients with retinitis pigmentosa, age-related macular degeneration, or similar degenerative diseases of the eye were stimulated using bundles of insulated platinum wire. The patients were under local anesthesia, and they described seeing points of light which correctly corresponded with the region of the retina in which the stimulus was applied (Humayun, M., et al., Archiv. Ophthalmol., 114: 40-46, 1996). The form of the stimulating device was, however, not suited for chronic implantation. The threshold for perception was reported to be in the range of 0.16-70 mC/cm.sup.2. This confirmed the results of earlier experiments on animal subjects by the instant inventors and others which indicated that strong evoked cortical potentials could be observed when rabbit retinas were stimulated using passive microfabricated electrode arrays similar in some respects to the ones proposed in the current invention (Rizzo, J. F., et al., ARVO Poster Session Abstract, Investigative Ophthalmology and Visual Science, 37: S707, 1996; Walter, P., et al. Investigative Ophthalmology and Visual Science, 39: S990, 1998). The instant inventors have, with others, performed three surgical procedures using microfabricated electrode arrays and similar in technique to those described by Humayun and confirmed that a consistent response to input electrical stimuli could be noted by the patient.
The task of creating a retinal implant has been addressed by Chow, in U.S. Pat. No. 5,016,633, who proposed a subretinal implant based on a microphotodiode array. The procedure involved in its implantation is so biologically intrusive, however, that successful implementation of such a device in human subjects has not been reported. Furthermore, an entirely passive array will be rather insensitive under normal lighting conditions, and an array powered from outside the body by means of a direct electrical connection will likely lead to infections and again, be so intrusive as to be objectionable.
Earlier designs of the present inventors placed all components of the prosthesis on the retinal surface (U.S. patent application Ser. No. 19/074,196, filed May 7, 1998, and U.S. Pat. No. 5,800,530, both of which are incorporated herein by reference). It became quickly apparent that the delicate retina could not withstand the mechanical burden which was at least partially the result of the relatively thick profile of the microelectronic components. A later prototype included one significant change in design--the bulky microelectronic components were moved anteriorly within the eye, off of the retinal surface. In this configuration, the microelectronics are held in a custom-designed intraocular lens, and only a thin ribbon containing the microelectrodes extends rearwardly to the retinal surface.
In summary, the present invention is a contribution to an ongoing area of development of visual prostheses which embodies the state of the art in both silicon processing technology and our understanding of the mechanisms underlying phosphene generation in human retinas by surface electrical stimulation. The feasibility of creating a chronically implantable retinal prosthesis capable of restoring some useful vision to blind patients over at least several degrees of their former field of view has been demonstrated.